Atricure Inc: Medical Device Recall in 2013 - (Recall #: Z-0912-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

Product Classification:

Class II

Date Initiated: January 14, 2013

Date Posted: March 13, 2013

Recall Number: Z-0912-2013

Event ID: 64404

Reason for Recall:

Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.

Status: Terminated

Product Quantity: 5 devices

Code Information:

Model Number(s): MAX1 A000163, Lot Number 41865

Distribution Pattern:

Nationwide Distribution including the states of MD, PA and TX.

Voluntary or Mandated:

Voluntary: Firm initiated